Infusion set and/or patch pump having at least one of an in-dwelling rigid catheter with flexible features and/or a flexible catheter attachment

ABSTRACT

An infusion set, patch pump, or elements thereof, having an exemplary catheter (14) provided with one or more channels, grooves and coatings (24, 34, 44), configured and arranged to provide a degree of strength and flexibility. The catheter (14) can also have an exemplary flexible union with the hub (12) having at least one of a ball-and-socket joint (66, 68), a sliding plate (86), and a flexible bushing (106), and which is sealed to allow even further movement of the catheter (14) while preventing leakage of medication through the junction. In doing so, a number of benefits associated with the use of rigid materials in catheter construction can be provided while at the same time, benefits associated with the use of flexible materials in catheter construction and/or flexible engagement with the hub can also be provided.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.17/239,066, filed Apr. 23, 2021, which is a division of U.S. patentapplication Ser. No. 15/720,791 filed Sep. 29, 2017, now U.S. Pat. No.11,013,854, issued May 25, 2021, which is a division of U.S. patentapplication Ser. No. 13/138,128, filed Sep. 1, 2011, now U.S. Pat. No.9,782,536, issued Oct. 10, 2017, which is the U.S. national stage ofInternational Application No. PCT/US2010/000054, filed on Jan. 11, 2010,which claims the benefit under 35 U.S.C. § 119(a) of U.S. ProvisionalPatent Application Ser. No. 61/144,072, filed Jan. 12, 2009, and alsoclaims the benefit under 35 U.S.C. § 120 as a continuation-in-part ofU.S. patent application Ser. No. 12/585,061, filed Sep. 2, 2009, nowU.S. Pat. No. 9,375,529, issued Jun. 28, 2016, the entire contents,disclosure and subject matter of each of said applications beingexpressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to components and elements ofinfusion sets and/or patch pumps, including a catheter having both rigidand flexible features desirable to users to minimize the risk ofocclusion, kinking, and other undesired issues such as tissueinflammation and foreign body response, while maintaining a degree ofcomfort to the user.

BACKGROUND OF THE INVENTION

A large number of people, including those suffering from conditions suchas diabetes use some form of infusion therapy, such as daily insulininfusions to maintain close control of their glucose levels. Currently,in the insulin infusion treatment example, there are two principal modesof daily insulin therapy. The first mode includes syringes and insulinpens. These devices are simple to use and are relatively low in cost,but they require a needle stick at each injection, typically three tofour times per day. The second mode includes infusion pump therapy,which entails the purchase of an insulin pump that lasts for about threeyears. The initial cost of the pump can be significant, but from a userperspective, the overwhelming majority of patients who have used pumpsprefer to remain with pumps for the rest of their lives. This is becauseinfusion pumps, although more complex than syringes and pens, offer theadvantages of continuous infusion of insulin, precision dosing andprogrammable delivery schedules. This results in closer blood glucosecontrol and an improved feeling of wellness.

Recently, another type of infusion pump known as a “patch pump” hasbecome available. Unlike a conventional infusion pump, a patch pump isan integrated device that combines most or all of the fluid componentsin a one-piece housing which is adhesively attached to an infusion site,and does not typically require the use of a separate infusion (tubing)set.

As patients on oral agents eventually move to insulin and their interestin intensive therapy increases, users typically look to insulin pumpsfor improvements in the management of their condition. Therefore,interest in better pump-related therapy is on the rise. In this andsimilar examples, what is needed to fully meet this increased interestare advanced, improved, and novel components and elements of current andfuture insulin infusion sets and/or patch pumps, including features andelements in the areas of catheter design, construction andimplementation to, for example, minimize the risk of occlusion, kinking,and other undesired issues such as tissue inflammation and foreign bodyresponse, while maintaining a degree of comfort to the user.

Existing infusion set and/or patch pump catheters are manufactured ofeither rigid material, such as stainless steel, or soft materials, suchas soft plastic, fluorinated polymers, and so forth. However, the softplastic catheters are prone to kink or occlude with normal wear, and therigid catheters are often found to be uncomfortable, since the rigidcatheter moves around within the tissue. Both soft plastic catheters andrigid catheters can also exhibit other undesired issues such as tissueinflammation and foreign body response.

Kinking is considered to be the cessation of flow through the catheter,due to mechanical causes, such as sliding back (accordion or bellows) orfolding back on the introducer needle during insertion. This failuremode could be the result of insufficient interference between the innerdiameter of the catheter and the outer diameter of the introducerneedle, a blunt end on the lead end of the catheter allowing excessforce to be transmitted to the catheter as the catheter initiallypenetrates the outer surface of the skin, or excessive bounce orvibration in the insertion mechanization, again resulting in excessiveforce being transmitted to the catheter. Kinking can also occur duringthe infusion or use cycle. A typical cause of this failure is theplacement of the catheter into tissue which undergoes significantmovement during physical activity.

Occlusion is the cessation of flow due to biologic or pharmacologiccauses, and these failures typically occur during the use cycle.Depending on the level of irritation caused by the catheter and themovement allowed by the catheter hub, the tissue can become inflamed aspart of a foreign body response, resulting in reduced insulin uptake.Further, there is a tendency for insulin to crystallize when flow isreduced to a minimum (low basal flow) or temporarily stopped, e.g. forbathing, swimming or extended periods, during which time the set isdisconnected. Insulin crystallization allowed to proliferate willultimately occlude the catheter to where the required pump pressure willexceed the normal flow conditions of the pump and trigger an alarm.

Insulin infusion devices currently available on the market incorporateeither a flexible polymer catheter, such as Teflon®, or a rigidcatheter, such as a stainless steel cannula. In the case of the latter,the cannula has a sharp, which is used to pierce the skin, similar to anintroducer needle in a conventional inserter. There are two productswith in-dwelling stainless steel cannulae currently marketed for insulininfusion, the SURE-T by Medtronic and the Orbit Micro by ICU Medical.These products are recommended for individuals who have a high incidenceof kinking. Unfortunately, these products are not recommended for usebeyond two days, because they can occlude for the reasons mentionedabove. Aside from these two products, the remaining marketed infusionsets have catheters which are manufactured from polymers, such asTeflon®.

Further, currently available patch pumps and infusion sets typicallyinclude catheters which are rigidly affixed to the hubs. This type ofjunction may strain the catheter and/or the tissue, such as when theskin slides atop the subcutaneous tissue. Such strain on a flexiblecatheter may lead to kinking, occlusion, or removal from the site. Suchstrain on a rigid catheter, such as a stainless steel catheter, may leadto discomfort and/or acute tissue trauma, i.e. inflammation, as thecatheter moves around within the tissue.

Accordingly, a need exists for advanced, improved, and novel componentsand elements of current and future infusion sets and/or patch pumps,that further provide catheter design, construction and implementationto, for example, minimize the risk of occlusion, kinking, and otherundesired issues such as tissue inflammation and foreign body response,while maintaining a degree of comfort to the user.

SUMMARY OF THE INVENTION

An object of the present invention is to substantially address the aboveand other concerns, and provide advanced, improved, and novel componentsand elements of current and future infusion sets and/or patch pumps,that further provide simplicity in manufacture and use improvements forboth insulin and non-insulin applications.

Another object of the present invention is to provide an exemplarycatheter design, construction and implementation to, for example,minimize the risk of occlusion, kinking, and other undesired issues suchas tissue inflammation and foreign body response, while maintaining adegree of comfort to the user.

Another object of the present invention is to provide a hub with afixedly attached catheter extending therefrom having a design,construction and implementation to, for example, minimize the risk ofocclusion, kinking, and other undesired issues such as tissueinflammation and foreign body response, while maintaining a degree ofcomfort to the user.

Another object of the present invention is to provide an exemplarycatheter which extends from the hub such that one or more lengths of thecatheter are constructed of a rigid material.

Another object of the present invention is to provide an exemplarycatheter wherein the rigid materials include one or more of a stainlesssteel, nitinol, titanium, rigid plastic, such as polycarbonate or TOPAS™which is a COC, or other similar material.

Another object of the present invention is to provide an exemplarycatheter having a substantially flexible length in contact with the userfor use in subcutaneous (SC) infusions, intradermal (ID) infusions,intramuscular (IM) infusions, and intravenous (IV) infusions.

Another object of the present invention is to provide an exemplarycatheter wherein the catheter is provided with a series and/or patternof channels or grooves through the wall of the catheter at specificlocations to allow the desired degree of flexibility.

Another object of the present invention is to provide an exemplarycatheter wherein the channels or grooves are configured and arranged tooptimize column strength for catheter insertion, flexibility for usercomfort, and tensile strength for durability, insertion and removal.

Another object of the present invention is to provide an exemplarycatheter wherein the channels or grooves are configured through thevariation of channel width, channel length, bridge between channelwidth, width of each course between parallel channels, angle or pitch ofchannels, and number of courses, to achieve for example, optimizedcolumn strength for catheter insertion, flexibility for user comfort,and tensile strength for durability, insertion and removal.

Another object of the present invention is to provide an exemplarycatheter wherein the channels or grooves are configured and arranged totarget a desired minimum bend radius of the distal section of thecatheter as well as a desired maximum arc of displacement.

Another object of the present invention is to provide an exemplarycatheter wherein the channels or grooves are configured and arranged toprovide additional surface area for medication delivery in subcutaneous(SC) infusions, intradermal (ID) infusions, intramuscular (IM)infusions, and intravenous (IV) infusions.

Another object of the present invention is to provide an exemplarycatheter arrangement for infusion to more than one infusion site type,e.g. intradermal (ID) and subcutaneous (SC), simultaneously or eachintermittently throughout the recommended use duration of the infusiondevice.

Another object of the present invention is to provide an exemplarycatheter wherein the channels or grooves can be constructed using lasermachining, electrical discharge machining (EDM), metal injection molding(MIM), plastic injection molding, chemical etching, or similartechniques.

Another object of the present invention is to provide an exemplarycatheter wherein at least one portion of the catheter body is providedwith a coating, such as a flexible sleeve or over-molded coating/sleeve,to provide further optimized column strength for catheter insertion,flexibility for user comfort, and tensile strength for durability,insertion and removal.

Another object of the present invention is to provide an exemplarycatheter wherein the catheter tip can be beveled or sharpened tofacilitate insertion through the user's skin.

Another object of the present invention is to provide an exemplarycatheter wherein the catheter can be comprised as a cannula or needlewith one or more of the features described above, and act as both aninsertion cannula or needle, and an in-dwelling catheter.

Another object of the present invention is to provide an exemplarycatheter and hub engagement wherein a flexible union is provided betweenthe catheter and hub to enable the catheter to be embedded into theuser's skin, and to move relative to the hub.

Another object of the present invention is to provide an exemplaryflexible union between a catheter and hub comprising at least one of aball-and-socket joint, a sliding plate, and a flexible bushing.

Another object of the present invention is to provide an exemplaryflexible union between a catheter and hub which is sealed to allowdesired movement while preventing leakage of medication through thejunction.

Another object of the present invention is to provide two separate hubsas part of one infusion device, the outer hub and the catheter hub, eachattached to the surface of the skin with a separate adhesive and theinsulin flow between the two accomplished through a flexible fluid lineor other similar connections means to isolate shock or applied forcesfrom the surface of the outer hub to the catheter.

Another object of the present invention is to provide a polymer sleeve,such as Teflon® or Vialon®, which can be used to cover the stainlesssteel in-dwelling catheter and provide a bio-interface between thetissue and the needle and/or to also seal the slots in the flexiblein-dwelling cannula.

Another object of the present invention is to provide a system andmethod for the partial withdrawal of the introducer needle orin-dwelling rigid cannula to a point where the sharp tip is not exposedto tissue and where the rigidity of the cannula can inhibit kinking.

Another object of the present invention is to configure the two hubs,which can be attached to the surface of the skin as a single device, inwhich the inner hub is designed to maintain the catheter positionrelative to the tissue in which the catheter has been inserted, andthereby reduce and eliminate irritation of the tissue and the cascade ofevents resulting from a foreign body response.

These and other objects are substantially achieved by providing aninfusion set, patch pump, or elements thereof, having an exemplarycatheter wherein one or more lengths of the catheter wall are providedwith one or more channels or grooves, configured and arranged to providea degree of catheter flexibility. The infusion set, patch pump, orelements thereof, can also have an exemplary catheter and hub comprisinga flexible or rigid catheter, such as a catheter with or withoutchannels or grooves, wherein the catheter can be retracted within acatheter sleeve. The infusion set, patch pump, or elements thereof, canalso have an exemplary flexible union between the catheter and hubcomprising at least one of a ball-and-socket joint, a sliding plate anda flexible bushing (including a bellows joint), a flexible tubingconnection, and which is sealed to allow desired movement of thecatheter while preventing leakage of medication through the junction. Indoing so, a number of benefits associated with the use of rigidmaterials in catheter construction can be provided while, at the sametime, benefits associated with the use of flexible materials in catheterconstruction and/or flexible engagement with the hub can also beprovided, and more specifically, can be provided at targeted areas.

That is, for example, the grooves and channels, and any coatings such asa flexible sleeve or over-molded coating/sleeve thereon, and flexibleunions between the catheter and hub, can be configured to optimizestrength to avoid kinking, occlusion, and other undesired issues such astissue inflammation and foreign body response, and provide flexibilityfor user comfort. Additional benefits of such channels, grooves andcoatings can include but are not limited to providing additional surfacearea for medication delivery in subcutaneous (SC) infusions, intradermal(ID) infusions, intramuscular (IM) infusions, and intravenous (IV)infusions. Further, the flexible unions can increase the degrees offreedom associated with the junction of the catheter and hub.

BRIEF DESCRIPTION OF THE DRAWINGS

The various objects, advantages and novel features of the exemplaryembodiments of the present invention will be more readily appreciatedfrom the following detailed description when read in conjunction withthe appended drawings, in which:

FIG. 1 is a perspective view of an infusion set which can include one ormore exemplary elements in accordance with an embodiment of the presentinvention;

FIGS. 2A-2E are enlarged elevational views of exemplary rigid cathetershaving channels to provide a flexible distal tip in accordance with anembodiment of the present invention;

FIG. 3 is an enlarged elevational view of an exemplary rigid catheterhaving channels to provide a flexible distal tip in accordance withanother embodiment of the present invention;

FIG. 4 is an enlarged elevational view of an exemplary rigid catheterhaving channels to provide a flexible distal tip in accordance with yetanother embodiment of the present invention;

FIG. 5A is an enlarged perspective view of an exemplary catheter havingchannels to provide a flexible catheter in accordance with anotherembodiment of the present invention;

FIG. 5B is an enlarged cross-sectional view of the exemplary catheter ofFIG. 5A;

FIG. 5C is an enlarged cross-sectional view of an exemplary catheterconstructed of rigid plastic and having channels to provide flexibilityin accordance with another embodiment of the present invention;

FIG. 5D is an enlarged cross-sectional view of an exemplary catheterconstructed of rigid plastic and having channels to provide flexibilityin accordance with another embodiment of the present invention;

FIGS. 6A-6C are enlarged perspective views of an exemplary catheterhaving a coiled construction to provide a flexible catheter inaccordance with another embodiment of the present invention;

FIG. 7 is an enlarged cross-sectional view of an exemplary catheter andhub flexible union engagement comprising a ball-and-socket joint toprovide a flexible connection in accordance with yet another embodimentof the present invention;

FIG. 8 is an enlarged cross-sectional view of an exemplary catheter andhub flexible union engagement comprising a sliding plate junction toprovide a flexible connection in accordance with yet another embodimentof the present invention;

FIG. 9 is an enlarged cross-sectional view of an exemplary catheter andhub flexible union engagement comprising a bushing junction to provide aflexible connection in accordance with yet another embodiment of thepresent invention;

FIG. 10 is an enlarged cross-sectional view of an exemplary two-part hubwith a flexible catheter in accordance with another embodiment of thepresent invention;

FIG. 11 is an enlarged cross-sectional view of an exemplary two-part hubwith a flexible catheter in accordance with yet another embodiment ofthe present invention;

FIGS. 12A and 12B are an enlarged cross-sectional views of an exemplaryhub with a retractable insertion catheter that is either flexible orrigid in nature, in accordance with another embodiment of the presentinvention;

FIGS. 13A and 13B are enlarged cross-sectional views of an exemplary hubwith a retractable insertion catheter that is either flexible or rigidin nature, in accordance with yet another embodiment of the presentinvention;

FIG. 14 illustrates the slight retraction of the insertion catheter thatis either flexible or rigid in nature, within a sleeve to protect asharpened end;

FIG. 15A is an enlarged cross-sectional view of an exemplary infusioncatheter with formed rigid internal lumens and external polymer sleevein accordance with yet another embodiment of the present invention;

FIGS. 15B-15E are sectional views of the infusion catheter taken alongthe lines A-A, B-B, C-C, and D-D of FIG. 15A, respectively;

FIG. 16 illustrates an exemplary infusion pump with dual reservoirs anda dual lumen infusion set in accordance with an embodiment of thepresent invention;

FIG. 17A is an enlarged cross-sectional view of an exemplary infusioncatheter cast, molded or machined from a solid rod in accordance with anembodiment of the present invention;

FIG. 17B is a perspective view of the infusion catheter of FIG. 17A;

FIGS. 18A-18E illustrate an exemplary infusion catheter and formingsequence to produce such a multi-lumen cannula from a flat sheet inaccordance with an embodiment of the present invention;

FIG. 19 illustrates an exemplary infusion pump with two catheters, onefor infusion into intradermal (ID) tissue and one for infusion intosubcutaneous (SC) tissue in accordance with an embodiment of the presentinvention;

FIG. 20 illustrates an exemplary infusion pump and set with anelectronically controlled valve to selectively direct infusion to eitherthe intradermal (ID) tissue, the subcutaneous (SC) tissue, or both theintradermal (ID) tissue and subcutaneous (SC) tissue in accordance withan embodiment of the present invention;

FIG. 21A illustrates an exemplary fluidic valve configuration thatselectively directs low-pressure flow to subcutaneous (SC) tissue andhigh-pressure flow to intradermal (ID) tissue in accordance with anembodiment of the present invention, wherein the valve configuration isshown in the high-pressure state; and

FIG. 21B illustrates the fluidic valve configuration of FIG. 21A withthe valve configuration shown in the low pressure state.

Throughout the drawings, like reference numerals will be understood torefer to like parts, components and structures.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

The exemplary embodiments described below address such unmet needs andillustrate a number of advanced, improved, and novel components andelements of current and future infusion sets and/or patch pumps, thatfurther provide simplicity in manufacture and improvements in use forboth insulin and non-insulin applications. For example, reducing oreliminating catheter kinking, occlusion and other undesired issues suchas tissue inflammation and foreign body response, throughout the usecycle is an unmet need. Unlike the currently marketed products, theexemplary embodiments described in greater detail below are hybrids, andincorporate multiple materials, components, features, and motions incombination, to substantially reduce and eliminate the conditions thatresult in catheter kinking, occlusion and other undesired issues such astissue inflammation and foreign body response. Such exemplaryembodiments are presented in separate descriptions, although theindividual features of these embodiments can be combined in any numberof ways to meet the needs of the user.

As will be appreciated by one skilled in the art, there are numerousways of carrying out the examples, improvements and arrangements ofinsulin-associated devices disclosed herein. Although reference will bemade to the exemplary embodiments depicted in the drawings and thefollowing descriptions, the embodiments disclosed herein are not meantto be exhaustive of the various alternative designs and embodiments thatare encompassed by the disclosed invention.

The exemplary embodiments of the present device described belowillustrate a number of features and elements in the areas of catheterdesign, construction and implementation to, for example, minimize therisk of occlusion, kinking, and other undesired issues such as tissueinflammation and foreign body response, while maintaining a degree ofcomfort to the user. A collection of exemplary elements is shown by wayof the example in FIG. 1 which serves to introduce the embodiments ofthe present invention described in greater detail below.

FIG. 1 illustrates an exemplary infusion set 10 including the followingfeatures. As shown in FIG. 1 , the exemplary infusion set 10 cancomprise a hub 12, a catheter 14, a fluid line tubeset 16 and aconnector 18. Additional infusion set elements and detail are omittedfor clarity. Further, in an entirely self-contained patch device, thefluid line tubeset 16 and connector 18 are omitted. In the followingdescription, a number of exemplary embodiments of a catheter 14 andcatheter-hub 14/12 connection are described in greater detail, which canbe provided for use with the exemplary infusion set 10 or any number ofother similar devices.

As known to those skilled in the art, a catheter can comprise a polymertube that remains in-dwelling after an introducer needle is removed, forpurposes of providing fluid communication from the infusion set to theinfusion site. A cannula can comprise a rigid tube, which can alsoremain in-dwelling. However, many of the following exemplary embodimentsdescribed below incorporate hybrids, i.e. combinations of cannulae andcannulae features, and sleeves or catheters and catheter features, andfunction as in-dwelling, flexible cannulae. However, to simplify thediscussion, the hybrid, in-dwelling, flexible cannulae are simplydescribed as catheters.

As noted above, one or more lengths of the catheter wall of the catheter14 can be provided with one or more channels or grooves, and/or acoating such as a flexible sleeve or over-molded coating/sleeve,thereon, configured and arranged to provide a degree of flexibility. Indoing so, a number of benefits associated with the use of rigidmaterials in catheter construction can be provided while at the sametime, benefits associated with the use of flexible materials in catheterconstruction can also be provided, and more specifically, can beprovided at targeted areas. That is, for example, the grooves, channels,and/or coatings, can be configured to optimize strength to avoidocclusion, kinking, and other undesired issues such as tissueinflammation and foreign body response, and provide flexibility for usercomfort. If the catheter is not flexible, a greater degree of irritationand resulting inflammation can occur, causing a loss of patency orreduction in insulin uptake by the tissue at the infusion site, whichwill progressively degrade over time. Accordingly, the provision of aflexible catheter or catheter with a bio-interface facilitates thedesired biological process in the tissue at the infusion site.

Additional benefits of such channels or grooves can include but are notlimited to, providing additional surface area for medication delivery insubcutaneous (SC) infusions, intradermal (ID) infusions, intramuscular(IM) infusions, and intravenous (IV) infusions, forming a cannula orneedle with one or more of the features described above, to act as bothan insertion cannula or needle, and an in-dwelling catheter, and forminga multi-lumen catheter to enable infusion to one or more tissuelocations or types, either simultaneously or each intermittently, e.g.intradermal (ID) tissue and subcutaneous (SC) tissue. A number ofexemplary catheters will now be described individually in greaterdetail.

As noted above, existing infusion set catheters are manufactured ofeither rigid material, such as stainless steel, or soft materials, suchas soft plastic, fluorinated polymers, and so forth. However, the softplastic catheters are prone to kink and/or occlude with normal wear, andthe rigid catheters are often found to be uncomfortable and are notrecommended for use beyond two days, as the rigidity of the cathetercauses the user to feel movement within the tissue, and also causes flowcessation, due to movement in the tissue and the ensuing inflammatoryresponse in the tissue.

To resolve such issues associated with conventional catheterconstruction, design and implementation, exemplary embodiments of thepresent invention comprise improved and novel elements of an infusionset for the delivery, or infusion, of insulin or other medications to auser via, for example, subcutaneous (SC) infusions, intradermal (ID)infusions, intramuscular (IM) infusions, and intravenous (IV) infusions.For example, as noted above, the infusion set 10 typically comprises thehub 12 which includes the fixedly attached catheter 14, and the tubeset16. The tubeset 16 connects the hub 12 to an infusion pump or otherinsulin supply (not shown) via a connector 18. In doing so, the tubeset16 provides for fluid communication between the infusion pump reservoirand the hub 12.

The hub 12 can be affixed to a patient's skin surface (not shown) usingan adhesive (not shown) disposed on a lower surface of the hub. As shownin FIG. 1 , the catheter 14 preferably protrudes from the lower surfaceof the hub 12 at a substantially perpendicular angle for at least aportion, although embodiments of the present invention are not limitedthereto. The catheter 14 that extends from the lower surface of the hub12 can be comprised in part, or entirely of a rigid material such asstainless steel, nitinol, titanium, or a rigid plastic such as PEEK(Polyetheretherketone), polycarbonate, TOPAS™ which is a COC, or similarmaterials. However, a soft plastic catheter is prone to kink and/orocclude with normal wear, and a rigid catheter is often uncomfortable.

Accordingly, in exemplary embodiments of the present invention as shownin the enlarged views of FIGS. 2A-2E, 3, 4, 5A-5D, and 6 , a portion orlength of the catheter 14 which is in contact with the tissue of theuser is made flexible via a series or pattern of channels or grooves.The channels or grooves are designed to optimize column strength of thecatheter 14 for improved catheter insertion, provide flexibility foruser comfort, and further provide tensile strength for durability,insertion and removal. In exemplary embodiments, a portion of theoverall catheter length can extend inside the device and for purposes ofthe following descriptions, the catheter is recited as the portionextending from the hub, or alternately, the length of the catheter whichextends from the hub.

In the exemplary embodiments of the present invention described below,the catheter can be provided with sufficient integrity and with asharpened, self-piercing tip 30, to allow the catheter to be implantedwithout the assistance of a rigid sleeve or guide, which is currentlyneeded to pierce the tissue and resist damage to the catheter duringdeployment. Further, such exemplary embodiments of the present inventionreduce the need for an intricate deployment mechanization, therebyreducing the overall size of the inserter and potentially allowing theinserter to become an integral part of the infusion pump.

As shown in the exemplary embodiment of FIG. 2A, the catheter 14 a (notshown to size) is provided with a series or pattern of channels orgrooves 24. The catheter 14 a of FIG. 2A comprises an outer diameter 20,an inner diameter 22, and one or more grooves 24 etched, cut, molded, orotherwise created (i.e., laser cut or chemically etched) in and/orthrough the catheter wall. The grooves 24 in the exemplary embodimentshown, are provided at perpendicular angles to the inner/outer surfaces,and parallel to a bottom surface of the hub 12. Each groove 24 is spacedfrom adjacent grooves by uncut sections 26, and spaced from adjacentparallel grooves by uncut sections 28. Further, as shown in FIG. 2A, theuncut sections 26 are staggered such that at least one or more uncutsections 26 are not adjacent.

In an exemplary embodiment of the present invention, the grooves 24 canbe any suitable size, but preferably between 0.05 mm to 0.5 mm wide and0.5 mm to 1.0 mm long, the uncut sections 26 can be between 0.05 mm to1.0 mm long and as wide as the grooves 24, and the uncut sections 28between grooves 24 can be between 0.05 mm to 1.0 mm. The channels orgrooves are designed to provide flexibility in one, two, or more axis,and optimize column strength of the catheter for improved catheterinsertion, hoop strength of the catheter to prevent collapse or kinkingonce implanted, provide flexibility for user comfort, and furtherprovide tensile strength for durability, insertion and withdrawal.

In the embodiment shown in FIG. 2A, the series or pattern of channels 24are located near the end of the catheter 14 a. That is, the portion ofthe catheter 14 a closest to the hub 12 remains intact, and the seriesor pattern of channels 24 are provided near an opposite end of thecatheter 14 a. The series or pattern of channels 24 are ended at a pointnear a sharpened, self-piercing tip 30, which can be beveled orsharpened to facilitate insertion through the patient's skin. Anexemplary embodiment of such a sharpened, self-piercing tip 30 is shownin greater detail in FIGS. 5A, 5B and 6 , described in greater detailbelow. As shown in greater detail in FIGS. 5A, 5B and 6 , the sharpened,self-piercing tip 30 can comprise a radius cut to create a beveled tip.Where the catheter is provided with such a sharpened, self-piercing tipto allow the insertion, the catheter can act also as the insertionneedle, thereby further reducing the complexity of the insertion step.

Where the series or pattern of channels are positioned in a mannersuitable to do so, such channels can also be used for targeted fluidcommunication. However, where not positioned to do so, one or more ofthe channels can be sealed with a biointerface sheath or coating such asa flexible sleeve or over-molded coating/sleeve, as described in greaterdetail below.

In this or any other exemplary embodiment described below, the series orpattern of channels can be provided near one or both opposite ends ofthe catheter, or at any portion therebetween, or any combination ofeach. In still other exemplary embodiments, the substantial entirety ofthe catheter body can be provided with such series or pattern ofchannels. The exemplary embodiments shown are for illustrative purposesonly, and are not intended to limit the present invention to a specificdistribution area of the series or pattern of channels.

In an exemplary embodiment of the present invention, the catheter 14 acan be any suitable size, but preferably between 3.5 mm to 12 mm long,with an inner diameter 22 of between 0.20 mm to 0.78 mm and outerdiameter 20 of between 0.25 mm to 0.8 mm. The first groove 24 at thedistal end of the catheter 14 a can be provided between 0.5 mm and 2.0mm from the distal end of the catheter, and the last groove can beprovided between 2.5 mm to 3.0 mm from the base 12. In doing so, alength of catheter 14 a between 1.5 mm and 9.0 mm long is provided withthe channels 24. In some cases, where the first groove may interferewith the back angle of the sharp, the first groove may be provided at agreater distance from the distal end of the catheter. The channels orgrooves are designed to provide flexibility in one, two, or more axis,and optimize column strength of the catheter for improved catheterinsertion, strength of the catheter to prevent collapse or occlusiononce implanted, provide flexibility for user comfort, and furtherprovide tensile strength for durability.

In the exemplary embodiment shown in FIG. 2A, each of the channels 24are provided at perpendicular angles to the inner/outer surfaces, andparallel to a bottom surface of the hub 12. However, in this and otherexemplary embodiments of the present invention, the channels can beprovided at non-perpendicular angles.

A number of other exemplary embodiments of the present inventioncomprising channels provided at perpendicular angles to the inner/outersurfaces, and parallel to a bottom surface of the hub are shown in FIGS.2B-2E. As shown in FIG. 2B, the catheter can have alternating “upper”and “lower” channels 24 a.

In the exemplary embodiment shown in FIG. 2C, the catheter is shownhaving opposite “upper” and “lower” channels 24 b, and opposite “front”and “rear” channels 24 c (i.e., rotated 90 degrees from the upper andlower channels). The dimensions of the channels 24 b and 24 c aresimilar to those of FIG. 2B. In the exemplary embodiment shown in FIG.2D, the catheter is shown having opposite “upper” and “lower” channels24 d, but of lesser depth than those of FIG. 2B (i.e, the channels crossthe center-line in the embodiment of FIG. 2B to allow flexibility in alldirections, wherein the channels stop short or at the center-line in theembodiment of FIG. 2D). In the exemplary embodiment shown in FIG. 2E,the catheter is shown having only “upper” channels 24 e, and of greaterdepth than those of FIGS. 2B, 2C and 2D. In such embodiments, the width,depth, and other placement features of the channels can be used as afactor to permit degrees and direction of flexibility.

As shown in the exemplary embodiment of FIG. 3 , the catheter 14 b (notshown to size) can also be provided with a series or pattern of channelor grooves 34 which are configured in a saw-tooth pattern. The catheter14 b of FIG. 3 comprises the outer diameter 20, the inner diameter 22,and one or more grooves 34 etched, cut, molded, or otherwise created inand/or through the catheter wall. The grooves 34 in the exemplaryembodiment shown, are provided in a saw-tooth pattern relative to theinner/outer surfaces, and to a bottom surface of the hub 12. Each groove34 is spaced from adjacent grooves by uncut sections 36, and spaced fromadjacent grooves by uncut sections 38. In an exemplary embodiment, anangle 40 of between 10 degrees and 45 degrees can be used, but theinvention is not limited thereto. For example, in yet other embodimentsof the present invention, the grooves 34 can be provided in asubstantially sinusoidal pattern. Further, as shown in FIG. 3 , theuncut sections 36 can be staggered such that at least one or more uncutsections 36 are not adjacent.

In an exemplary embodiment of the present invention, the grooves 34 canbe any suitable size, but preferably between 0.05 mm and 0.5 mm wide and0.5 mm to 1.0 mm long, the uncut sections 36 can be between 0.05 mm to1.0 mm long and as wide as the grooves 34, and the uncut sections 38between grooves 34 can be between 0.05 mm to 1.0 mm.

In the exemplary embodiment shown in FIG. 3 , the series or pattern ofchannels 34 are also located near the end of the catheter 14 b. That is,the portion of the catheter 14 b closest to the hub 12 remains intact,and the series or pattern of channels 34 are provided near an oppositeend of the catheter 14 b. The series or pattern of channels 34 are endedat a point near a sharpened, self-piercing tip 30, which can be beveledor sharpened to facilitate insertion through the patient's skin.

In an exemplary embodiment of the present invention, the catheter 14 bcan be any suitable size, but preferably between 3.5 mm to 12 mm long,with an inner diameter 22 of between 0.20 mm to 0.78 mm and outerdiameter 20 of between 0.25 mm to 0.8 mm. The first groove 34 at thedistal end of the catheter 14 b can be provided between 0.5 mm and 2.0mm from the distal end of the catheter, and the last groove can beprovided between 2.5 mm to 3.0 mm from the base 12. In doing so, alength of catheter 14 b between 1.5 mm and 9.0 mm long is provided withthe channels 34. In some cases, where the first groove may interferewith the back angle of the sharp, the first groove may be provided at agreater distance from the distal end of the catheter.

In the exemplary embodiment shown, the catheter provides a means (i.e.,cross-porting) for transferring drug to the infusion site tissue, andtherefore the slots do not extend all the way back to the proximal endof the catheter. This distance, approximately 3 mm, is intended toposition the cross-ports into the SC tissue, and inhibit drug flow tothe intra-dermal (ID) tissue. For the concepts shown in images 2B, 2C,2D, 2E, 5A, 5B, 5C, 5D, 6, 10, 11, 12A, 12B, 13A, 13B, and 14 thecatheter has been rendered flexible from a distance starting just behindthe bevel of the tip and extending into the infusion set hub to allowthe flexible catheter to “snake” from the flat plane or axis of the hubto enter and extend into the tissue perpendicular to that axis.

As shown in the exemplary embodiment of FIG. 4 , the catheter 14 c canalso be provided with a series or pattern of channels or grooves 44which are configured in a helix pattern oriented about a center axis ofthe catheter. A helix is a three-dimensional coil that runs along thesurface of a cylinder, in this case, the body of the catheter. Thecatheter 14 c of FIG. 4 comprises the outer diameter 20, the innerdiameter 22, and one or more grooves 44 etched, cut, molded, orotherwise created in and/or through the catheter wall. The grooves 44 inthe exemplary embodiment shown, are provided in a helix pattern relativeto the inner/outer surfaces, and to a bottom surface of the hub 12, andoriented about a center axis of the catheter. Each groove 44 is spacedfrom adjacent grooves by uncut sections 46, and spaced from adjacentgrooves by uncut sections 48. Further, as shown in FIG. 4 , the uncutsections 46 are staggered such that at least one or more uncut sections46 are not adjacent.

In an exemplary embodiment of the present invention, the grooves 44 canbe any suitable size, but preferably between 0.05 mm and 0.5 mm wide and0.5 mm to 1.0 mm long, the uncut sections 46 can be between 0.05 mm to1.0 mm long and as wide as the grooves 44, and the uncut sections 48between grooves 44 can be between 0.05 mm to 1.0 mm.

In the embodiment shown in FIG. 4 , the series or pattern of channels 44are also located near the end of the catheter 14 c. That is, the portionof the catheter 14 c closest to the hub 12 remains intact, and theseries or pattern of channels 44 are provided near an opposite end ofthe catheter 14 c. The series or pattern of channels 44 are ended at apoint near a sharpened, self-piercing tip 30, which can be beveled orsharpened to facilitate insertion through the patient's skin.

In an exemplary embodiment of the present invention, the catheter 14 ccan be any suitable size, but preferably between 3.5 mm to 12 mm long,with an inner diameter 22 of between 0.20 mm to 0.78 mm and outerdiameter 20 of between 0.25 mm to 0.8 mm. The first groove 44 at thedistal end of the catheter 14 c can be provided between 0.5 mm and 2.0mm from the distal end of the catheter, and the last groove can beprovided between 2.5 mm to 3.0 mm from the base 12. In doing so, alength of catheter 14 c between 1.5 mm and 9.0 mm long is provided withthe channels 44. In some cases, where the first groove may interferewith the back angle of the sharp, the first groove may be provided at agreater distance from the distal end of the catheter.

As noted above, in still other exemplary embodiments, the substantialentirety of the catheter body between distal and proximal ends can beprovided with such series or pattern of channels. In this case, theseries or pattern of channels may not be positioned for fluidcommunication and therefore, one or more of the channels can be sealedwith a biointerface sheath or coating such as a flexible sleeve orover-molded coating/sleeve, as described in greater detail below.

Through the use of the exemplary embodiments described above, a devicecan be configured to provide a cannula or needle with one or more of thefeatures described above, to act as both an insertion cannula or needle,and an in-dwelling catheter. One such exemplary embodiment is shown inFIGS. 5A and 5B, and preferably comprises a rigid catheter 14 d (forexample, stainless steel), with a sharpened, self-piercing tip 30 andalternating, parallel slots 52, etched, cut, molded, or otherwisecreated (i.e., laser cut or chemically etched) in and/or through thecatheter wall, along the substantially entire shaft of the catheter. Theslots 52 can be provided substantially as described above in regard tothe exemplary embodiment of FIGS. 2A-2E, wherein spacing between slots52 can be configured to provide the slight overlap of the slot ends asshown, or as described above in regard to the exemplary embodiment ofFIGS. 3 and 4 . However, as the exemplary embodiments of the presentinvention are described in regard to catheter gauges of 24 to 34 gauges,at extreme values, the above numerical dimensions can result in aslot/spacing relationship that can change. For example, for a 34 gaugecatheter, the shortest length slot, i.e., 0.5 mm long, would only allowone attachment point around the diameter, which could limit designalternatives and device performance.

Accordingly, as illustrated in FIG. 5B, the catheter of extreme values,or any value therebetween, can be designed to have a wall thickness of T(i.e., with an outside diameter of approximately 3T, and an insidediameter of approximately T). In doing so, each of channels 52 can bebetween 1T to 6T wide, and preferably between 2T and 3T. The uncutspaces between channels can be between 1T and 6T, and preferably between2T and 3T.

In the embodiment of FIGS. 5A and 5B, the alternating slots 52 enablethe catheter 14 d to flex, yet provide a rigidity or column strengthnecessary for insertion into the user's skin, but flex to provide acomfortable in-dwelling catheter. The exemplary stainless steel catheter14 d is preferably a unitary body having a sharpened, self-piercing tip30 at the distal end. As shown in FIG. 5A, the sharpened, self-piercingtip 30 can comprise a radius cut to create a beveled tip. Where thecatheter is provided with such a sharpened, self-piercing tip to allowthe insertion, the catheter can act as the insertion needle, therebyfurther reducing the complexity of the insertion step.

Further, as shown by the exposed illustrative portion of FIG. 5A, thecatheter 14 d can be sheathed or coated over some desired portion by acoating, such as Vialon® or Teflon®, to create a sleeve 54 a thatprovides a biocompatible outer fluid seal for enabling a drug fluid toenter to the user through the tip of the catheter, provide a seal sothat leakage does not occur through the slots 52, and/or provide a coverinto which the insertion cannula or in-dwelling catheter can be slightlyretracted to cover the sharpened end thereof.

The outer sheath or sleeve 54 a can be processed to the appropriateinner diameter and pulled over the catheter 14 d for attachment.Depending on the specific sheath or sleeve material, the attachment maybe facilitated by a dip coating process, heat shrinking, bonding, or anyother suitable process. The outer sheath or sleeve 54 a can comprise apolymer sleeve, such as Teflon® or Vialon®, which can be used to coverthe stainless steel in-dwelling catheter and provide a bio-interfacebetween the tissue and the needle and/or to also seal the slots in theflexible in-dwelling cannula. Additional disclosure of the exemplaryVialon® material can be found in commonly assigned U.S. Pat. Nos.5,226,899 and 5,453,099 of Min-Shiu Lee et al., U.S. Pat. No. 5,545,708of Theo Onwunaka et al., and U.S. patent application Ser. No. 12/585,061of Gary Searle et al., the entire contents, disclosure and subjectmatter of each being expressly incorporated herein by reference. In yetother exemplary embodiments of the present invention, any suitable fluidtight material could be used to form the sheath or coating such as theflexible sleeve or over-molded coating/sleeve. In this or otherexemplary embodiments of the present invention, a material which canbecome softer and/or more flexible once inserted can also be used.

Such polymers, overmolding, and other construction techniques andmaterials can be used in the construction of the in-dwelling cannula orcatheter. For example, FIGS. 5C and 5D are enlarged cross-sectionalviews of a portion of exemplary catheters constructed of rigid plasticand having channels to provide flexibility in accordance withembodiments of the present invention.

In FIG. 5C, an exemplary catheter 14 e is shown constructed of injectionmolded rigid plastic, wherein the slots 24 f provide flexibility. As thecatheter 14 e is injection molded, the slots 24 f, needle point, and allother finished features can be molded in any configuration desired suchthat no secondary operations would be required. Further, as with theembodiment shown in FIG. 5A, an over-molded outer sheath or sleeve 54 bcan comprise a polymer, such as Teflon® or Vialon®, and be used to coverthe catheter, provide a bio-interface between the tissue and thecatheter, and/or seal the slots in the catheter.

A similar exemplary embodiment is shown in FIG. 5D in which an exemplarycatheter 14 f is shown constructed of injection molded rigid plastic,wherein the slots 24 g provide flexibility. As the catheter 14 f isagain injection molded, the slots 24 g, needle point, and all otherfinished features can be molded in any configuration desired such thatno secondary operations would be required. Further, an extruded outersheath or sleeve 54 c can comprise a polymer sleeve, such as Teflon® orVialon®, and be used to cover the catheter, provide a bio-interfacebetween the tissue and the catheter, and/or seal the slots in thecatheter. In the exemplary embodiments, the outer sleeve can beover-molded as part of a 2-shot molding process, or can be extrudedseparately and assembled to the insertion cannula or in-dwellingcatheter.

Still another exemplary embodiment wherein the substantially entirecatheter body can be provided with such series or pattern of channels isshown in FIG. 6A, and preferably comprises a catheter 14 g with asharpened rigid, such as stainless steel, needle tip 32, attached to atorsion spring 56. The needle tip 32 and sharpened, self-piercing tip 30thereof, enables penetration into the user's skin and is preferablywelded to the torsion spring 56, but may be attached using any suitablemethod.

The torsion spring 56 provides similar benefits as the embodimentsdescribed above in that it provides column strength for insertion,flexibility for user comfort, and tensile strength for durability. Sucha torsion spring 56 can be sheathed or coated over some desired portionby a coating such as a flexible sleeve or over-molded coating/sleevematerial, such as a Vialon® or Teflon® sleeve 58 for sealing thecommunicated fluid within the inner cavity of the torsion spring.

In another exemplary embodiment shown in FIG. 6B, the torsion spring 57can also be laser cut or chemically etched from the proximal portion ofthe solid steel cannula, i.e. behind the sharp tip 30, by lasing acontinuous spiral or helix. In this case, the proximal end could eitherbe opened or closed (i.e., open to deliver contents, or closed to urgecontent delivery through other openings). In doing so, the one-piecespiral or helix cut structure enables the shaft to be flexible, thecolumn strength to be maintained which enables insertion, and allowshoop strength to be maintained which prevents collapse of the innerlumen. As with the embodiments described above, the torsion spring 57can be sheathed or coated over some desired portion by a coating such asa flexible sleeve or over-molded coating/sleeve material, such as aVialon® or Teflon® sleeve 58 for sealing the communicated fluid withinthe inner cavity of the torsion spring.

In another exemplary embodiment shown in FIG. 6C, the torsion spring 56can be manufactured from a continuous length of torsion spring, and thenlasing a continuous weld to connect a number of coils at the end of thespring, and then grinding the welded end to create the bevel end 31. Aswith the embodiments described above, the torsion spring 57 can besheathed or coated over some desired portion by a coating such as aflexible sleeve or over-molded coating/sleeve material, such as aVialon® or Teflon® sleeve 58 for sealing the communicated fluid withinthe inner cavity of the torsion spring.

The exemplary catheters described above can be provided with anysuitable wire or spring cross section, inner diameter, and outerdiameter, and may alternatively comprise a rectangular cross-section tomaximize the internal diameter, as would be appreciated by one ofordinary skill in the art. Additionally, the ends of each do not need tocomprise an opening for the flow of drug to the user. It may desirableto implement an embodiment with a closed end, and having side portslocated near the tip or elsewhere for enabling the flow of drug to theuser. An exemplary catheter having a plurality of holes at or near atapered tip, and a method of constructing and using such a catheter isdescribed in U.S. patent application Ser. No. 12/427,633, filed Apr. 21,2009, entitled “Systems And Methods For Improving Catheter Hole ArrayEfficiency”, the entire contents, disclosure and subject matter of whichbeing expressly incorporated herein by reference. In other exemplaryembodiments, a flexible catheter can be coupled with a sharpened tipoptionally hardened relative to the catheter for entering the user'sskin.

An additional feature to be used in any of the above embodimentsprovides a means for heparinizing the catheter. Heparinization of thecatheter may be performed prior to initial insertion into the user'sskin or during the variable insertion and retraction motions.Heparinization may be performed by coating the catheter with heparin byany method available to one of ordinary skill in the art. A heparinizedcatheter may facilitate preservation of the infusion site by preventingblood coagulation at the infusion site which may block or otherwisecomplicate the infusion site. The drug Heparin is one in a family ofanti-coagulants and one of ordinary skill in the art would appreciatethat similar drugs can be substituted to achieve the same benefitswithout departing from the scope and spirit of embodiments of thepresent invention.

By providing a distal portion or length of the catheter which is incontact with the tissue of the user with the channels, a portion orlength of the catheter is made flexible, while maintaining a rigidportion or length of the catheter. The channels or grooves are designedto optimize column strength of the catheter for improved catheterinsertion, provide flexibility for user comfort, and further providetensile strength for durability.

In the construction, design and implementation of the catheter describedabove, the width of each channel, the length of each channel, width ofeach bridge or uncut sections between channels, width of uncut sectionsbetween parallel channels, angle or pitch of channels relative to theaxis of the catheter, and the number of courses, can be determined toprovide a desired minimum bend radius of the distal section of thecatheter axis, and the maximum arc of displacement. The channels orgrooves can be configured to pass entirely through the thickness of thecatheter, or can be configured to pass through one wall of the catheter,that is, entirely between the outer and inner surfaces or some portionthereof. In these and other embodiments of the present invention, acombination of any of the above configured grooves or channels can beprovided as desired. That is, one or more of the grooves or channelsillustrated in FIGS. 2-6 , including the coatings or sheaths, can beprovided in a single catheter.

Further, as noted above, the presence of the channels or grooves at thedistal section of the catheter also allows additional surface area formedication delivery to the tissue of the user. That is, when a substanceis delivered to a targeted area via the catheter, some delivery occursvia the provided grooves or channels when desirable to do so. In otherexemplary embodiments, the catheter can be sheathed or coated over somedesired portion by a coating, such as Vialon® or Teflon®, to create asleeve that provides a biocompatible outer fluid seal for enabling adrug fluid to enter to the user through the tip of the catheter, andprovide a seal so that leakage doesn't occur through the slots.

Still further, in each embodiment of the present invention, the channelsor grooves can be constructed using laser machining, electricaldischarge machining (EDM), metal injection molding (MIM), plasticinjection molding, chemical etching, or similar techniques, such thatthe channels or grooves are cleanly cut through the wall of the catheterwithout creating obstacles, undesired edges, or dead spaces.

If required, the catheter can be reworked (i.e. a secondary operation)after the process used to induce flexibility, e.g. laser cutting, EDM,chemical etch, etc. For example, electropolishing can be used to removesurface imperfections, and create an oxide layer for improvedbiocompatibility and corrosion resistance. Passivation can be used withstainless steel and catheters produced from other metals with someamount of ferrous composition, e.g. nitinol, to remove ironcontamination from the surface. Microblasting can also be used toestablish a clean, textured surface for over-molding.

Further, where the catheter is provided with both flexible and rigidfeatures, and the sharpened, self-piercing tip, thereby allowing theinsertion of the catheter without the use of an insertion needle, thecatheter can act as the insertion needle and can remain in-dwelling,thereby further reducing the complexity of the insertion step. Such acatheter can be sheathed or coated over some desired portion by acoating such as a flexible sleeve or over-molded coating/sleevematerial, such as a Vialon® or Teflon® sleeve.

In the above described and other exemplary embodiments of the presentinvention, further benefit can be achieved by providing a flexible unionbetween the catheter and the hub. Currently available patch pumps andinfusion sets typically include catheters which are rigidly affixed tothe hubs. This type of junction may strain the catheter and/or thetissue, such as when the skin slides atop the subcutaneous tissue. Suchstrain on a flexible catheter may lead to kinking, occlusion, or removalfrom the site. Such strain on a rigid catheter, such as a stainlesssteel catheter, may lead to discomfort and/or acute tissue trauma as thecatheter moves around within the tissue.

Accordingly, exemplary embodiments of the present invention are furtherprovided to enable the hub to move with the skin while minimizing anyeffect of such movement on the catheter and the insertion site. Examplesof such a flexible union can be provided by, but are not limited to, aball-and-socket joint, a sliding plate junction, a separate inner hubwith a separate adhesive attachment a flexible tubing connection, and aflexible bushing junction (including a bellows connection or bellowsjoint), provided between the catheter and the hub or patch pump.

Still further embodiments of the present invention can comprise two ormore separate hubs as part of one infusion device, such as the outer huband the catheter hub, each attached to the surface of the skin with aseparate adhesive and wherein the flow between the two is preferablyaccomplished through a flexible fluid line or other similar connectionsmeans to isolate shock or applied forces from the surface of the outerhub to the catheter. The two hubs, which can be attached to the surfaceof the skin as a single device, can be further configured such that theinner hub maintains the catheter position relative to the tissue inwhich the catheter has been inserted, and thereby reduce and eliminateirritation of the tissue and the cascade of events resulting from aforeign body response.

FIG. 7 is an enlarged cross-sectional view of a hub, such as providedwith a patch pump, incorporating one such exemplary catheter and hubengagement comprising a ball-and-socket joint in accordance with anembodiment of the present invention. In FIG. 7 , a hub 60 is shownhaving a fluid, medication or other content storing reservoir 62positioned above or in fluid communication with a catheter 64. A balljoint 66 can be secured or otherwise formed at one end of the catheter64, and is provided to rotatably secure the catheter 64 with the lowersurface of the hub 60.

Specifically, a lower portion of the hub 60 body can comprise a circulardetent opening 68 or other similar opening into which the ball joint 66of the catheter 64 can be captured. The circular detent opening 68 canbe sized to allow the ball joint 66 to be press-fit into and thereaftercaptured by the circular detent opening 68.

The ball joint 66 may also be captured within the circular detentopening 68 by manipulating one or more elements of the hub 60 to allowexpansion and contraction of the detent opening 68 to facilitateinstallation and thereafter capture of the ball joint 66 within thedetent opening 68, or the ball joint 66 may be captured within thedetent opening 68 during the assembly of the body of the hub 60. Indoing so, the catheter 64 is free to rotatably move relative to the hub60 in a number of directions, such as those illustrated by thedirections of arrows A and B. That is, the catheter 64 of FIG. 7 is freeto rotate to the extent permitted by a bottom opening 70 of the detentopening 68 in the lower surface of the body of the hub 60.

The catheter 64 can comprise any suitable catheter, such as thosedescribed above, and the ball joint 66 can be formed of a materialidentical or similar to that of the catheter 64, and can comprise anopening therethrough to allow uninterrupted fluid communication duringrotation and at each rotated position of the catheter 64 and ball joint66.

Further, the junction between the catheter 64 and the hub 60 can besealed to prevent leakage either from the chamber 62 or into the chamber62, by one or more sealing elements 72. The sealing element 72 cancomprise any number of suitable elements, such as one or more O-rings,bushings, washers, molded elements or similar sealing elements. Thesealing element 72 can be further configured to control the rotatablemovement of the catheter 64 by providing a degree of friction betweenthe ball joint 66 of the catheter 64 and the hub 60. The hub 60 canfurther comprise additional elements, such as the adhesive layer 74 tosecure the hub 60 to a skin surface for use, and still other elementswhich are omitted from the illustration of FIG. 7 for clarity.

In an exemplary embodiment of the present invention, the ball joint 66can comprise a substantially circular element having a diameter of anysuitable size, but preferably between 0.5 mm to 4.0 mm. Accordingly, thedetent opening 68 can have a diameter between 0.5 mm to 5.0 mm, and thebottom opening 70 of the detent opening can have a diameter between 0.4mm to 3.8 mm wide. In embodiments of the present invention, the bottomopening 70 can be circular, oval, or any shape desired to provide theneeded degrees of movement.

In yet other embodiments of the present invention, a sliding plate canbe provided to allow movement between the catheter and hub, and/or aflexible bushing can be provided to allow movement between the catheterand hub. Although degrees of movement are provided by each of theball-and-socket, sliding plate, and flexible bushing, subtle differencesin the movement provided by each (i.e., rotational, slidable, orcombinations thereof) can result in a preference for one exemplaryembodiment in a specific application.

For example, FIG. 8 is an enlarged cross-sectional view of a hub, suchas provided with a patch pump, incorporating an exemplary catheter andhub engagement comprising such a sliding plate junction in accordancewith another embodiment of the present invention. In FIG. 8 , a hub 80is shown having a fluid, medication or other content storing reservoir82 positioned above or in fluid communication with a catheter 84. Thecatheter 84 comprises an element at one end, such as the planar element86, which is slidably captured in an opening 88 to slidably secure thecatheter 84 with the lower surface of the hub 80.

Specifically, a lower portion of the hub body can comprise the opening88, formed between a lower surface of the chamber 82 and one or moreelements 90 captured in one or more notches 92, into which the planarelement 86 can be captured. In an exemplary embodiment of the presentinvention, the notch 92 is formed in an inner wall of the reservoir 82and encircles the entire circumference of the reservoir. Accordingly,the element 90 can comprise a substantially circular washer-shapedmember which can be assembled into the notch 92. A thickened portion ofthe element 90 can be provided to secure the element 90 into the notch92. A narrower portion of the element 90 can be provided near a centralopening 94 to allow a degree of deflection to assist in holding theplanar member 86 and sealing elements 96 described in greater detailbelow.

The planar element 86 can be captured within the opening 88 through theassembly of the hub body or in a similar manner. In doing so, thecatheter 84 is free to move relative to the hub 80 in a number ofdirections, such as those illustrated by the directions of arrows A′ andB′. That is, the catheter 84 of FIG. 8 is free to slide to the extentpermitted by the bottom opening 98 in the lower surface of the hub 80,and/or as permitted by the travel of the planar member 86 within theopening 88. Some rotational movement of the catheter 84 relative to thehub 80 can also be provided as permitted by the deflection of theelement 90 by the planar member 86 (see for example, the arrows A and Bof FIG. 7 ).

The catheter 84 can comprise any suitable catheter, such as thosedescribed above. The planar member 86 can be formed of a materialidentical or similar to that of the catheter 84, and can comprise anopening therethrough to allow uninterrupted fluid communication duringsliding and at each position. The securing element 90 can also be formedof a material identical or similar to that of the planar member 86, thehub 80, or any other suitable material.

Further, the junction between the catheter 84 and the hub 80 can besealed to prevent leakage either from the chamber 82 or into the chamber82 by one or more sealing elements 96. The sealing elements 96 cancomprise any number of suitable elements, such as O-rings, bushings,washers, molded elements or similar sealing elements. In yet otherexemplary embodiments of the present invention, a U or cup shaped, Xshaped or other type of wipe seal can be used, and provide additionalbenefits in that the sealing forces are reduced. The sealing elements 96can be further configured to control the slidable movement of thecatheter 84 by providing a degree of friction between the planar member86 of the catheter 84 and the walls of the opening 88 of the hub 80. Thehub 80 can further comprise elements such as the adhesive layer 74 tosecure the hub to a skin surface for use.

In an exemplary embodiment of the present invention, the planar member86 can be circular, oval, or any shape desired to provide the neededdegrees of movement. In an exemplary embodiment of the present inventionthe planar member 86 can comprise a substantially circular elementhaving a diameter of any suitable size, but preferably between 1.0 mm to10.0 mm and a thickness of between 0.5 mm to 1.0 mm. Accordingly, thebottom opening 98 can have a diameter between 1.0 mm to 5.0 mm. Inembodiments of the present invention, the bottom opening 98 can becircular, oval, or any shape desired to provide the needed degrees ofmovement.

In yet another example, FIG. 9 shows an enlarged cross-sectional view ofa hub, such as provided with a patch pump, incorporating an exemplarycatheter and hub engagement comprising a flexible bushing junction inaccordance with yet another embodiment of the present invention. In FIG.9 , a hub 100 is shown having a fluid, medication or other contentstoring reservoir 102 positioned above or in fluid communication with acatheter 104. A flexible bushing 106 can be secured or otherwise formedat one end of the catheter 104, and is provided to rotatably and/orslidably secure the catheter 104 with the lower surface of the hub 100.

Specifically, a lower portion of the hub body or reservoir 102 cancomprise an opening into which the flexible bushing 106 can be captured.The opening can be sized to allow the flexible bushing 106 to be pressfit into and thereafter captured by the lower portion of the reservoir102. The flexible bushing 106 may also be captured within the hub 100through the assembly of the hub body or in a similar manner. In doingso, the catheter 104 is free to move in a number of directions, such asthose illustrated by the directions of arrows A″ and B″. That is, thecatheter 104 of FIG. 9 is free to rotate to the extent permitted by theflexibility of the flexible bushing 106 and a bottom opening 110 in thelower surface of the body of the hub 100.

In an exemplary embodiment of the present invention, the flexiblebushing 106 can comprise an outer diameter sufficient to be captured ata lower portion of the reservoir 102. The bushing 106 can furthercomprise a reduced portion 108 having an outer diameter sufficient to becaptured within and seal the opening 110. To do so, exemplaryembodiments of the bushing 106 can be comprised of a soft, lowdurometer, flexible material, which can also be configured to create thefluid seal, and which creates a flexible joint between the catheter 104and the pump body or hub 100.

The catheter 104 can comprise any suitable catheter, such as thosedescribed above. The flexible bushing 106 can further comprise anopening therethrough to allow uninterrupted fluid communication duringrotation and/or sliding, and at each rotated or slid position. Further,the junction between the catheter 104 and the flexible bushing 106, andbetween the flexible bushing 106 and the hub 100 can be sealed toprevent leakage either from the chamber 102 or into the chamber 102 byselection of the materials of the flexible bushing 106 and/or by theselection of materials securing the flexible bushing 106 within the hub100. The hub 100 can further comprise elements such as the adhesivelayer 74 to secure the hub to a skin surface for use.

In an exemplary embodiment of the present invention, the flexiblebushing 106 can be circular, oval, or any shape desired to provide theneeded degrees of movement. In an exemplary embodiment of the presentinvention the flexible bushing 106 can comprise a substantially circularelement having diameter of any suitable size, but preferably between 2.0mm to 10.0 mm, and a diameter at the reduced portion 108 between 1.0 mmto 9.0 mm. Accordingly, the bottom opening 110 can have a diameterbetween 1.0 mm to 9.0 mm. In embodiments of the present invention, thebottom opening 110 can be circular, oval, or any shape desired toprovide the needed degrees of movement.

In each exemplary embodiment of the present invention described above,materials can be used which are compatible with both the contents of thedevice and which exhibit sufficient shelf life and sterilizationqualities as required. In doing so, the exemplary embodiments of thepresent invention can provide a flexible union between the catheter andthe hub.

As noted above, infusion sets and patch pumps are typically applied to auser's skin and have catheters that extend through the user's skin andinto the subcutaneous tissue or other tissue, depending upon thespecific use in either subcutaneous (SC) infusions, intradermal (ID)infusions, intramuscular (IM) infusions, and intravenous (IV) infusions.The catheters provide a fluid pathway for delivery of medication, suchas insulin, into the tissue. The above described exemplary embodimentsof the present invention enable the catheter, which is embedded in theuser's skin and tissue, to move either as a flexible catheter or moverelative to the hub, which is affixed to the user's skin. To do so, thecatheter can be provided with channels, grooves and coatings such as aflexible sleeve or over-molded coating/sleeve, and the junction of thecatheter to the hub can be comprised of a ball-and-socket joint, asliding plate, a flexible bushing, or similar design, to enable thecatheter to move and move relative to the hub. In each case, thejunction can be further configured to be sealed to prevent leakage ofcontents through the junction.

Further, where the catheter is provided with both flexible and rigidfeatures, and the sharpened, self-piercing tip, thereby allowing theinsertion of the catheter without the use of an insertion needle, thecatheter can act as the insertion needle and can remain in-dwelling,thereby further reducing the complexity of the insertion step.

Still further embodiments of the present invention can comprise anexemplary two-part hub with a flexible catheter as part of one infusiondevice. In an exemplary embodiment shown in FIG. 10 , a device havingtwo separate hubs as part of one infusion device, such as the outer huband the catheter hub, can each be attached to the surface of the skinwith a separate adhesive and the insulin flow between the two ispreferably accomplished through a flexible fluid line or other similarconnections means to isolate shock or applied forces from the externalsurface of the outer hub to the catheter. The two hubs, which can beattached to the surface of the skin as a single device, can be furtherconfigured such that the inner hub maintains the catheter positionrelative to the tissue in which the catheter has been inserted, andthereby reduce and eliminate irritation of the tissue and the cascade ofevents resulting from a foreign body response.

For example, such a device 120 is shown in FIG. 10 and comprises ahousing 122 and housing adhesive 124, and a needle hub 126 and needlehub adhesive 128. A flexible connection 130 is provided between theouter housing 122 and the needle hub 126. A minimal gap 132 is providedbetween the outer housing 122 and the needle hub 126, such that theouter housing 122 can provide an envelope for the attachment andlocation of the needle hub 126 therein, but any force or movementconveyed to the outer housing 122 is not transferred to the needle hub126.

Accordingly, the embodiment comprises a single device having twoseparate hubs 122 and 126 as part of one infusion device 120, whereineach can be attached to the surface of the skin with separate adhesivelayers 124 and 128 and the insulin flow between the two is accomplishedthrough the flexible fluid line or other similar connections means 130to isolate shock or applied forces from the external surface of theouter hub 122 to the catheter 134. The two hubs 122 and 126 can beattached to the surface of the skin as a single device, and can beconfigured such that the inner hub 126 maintains the catheter 134position relative to the tissue in which the catheter 134 has beeninserted, and thereby reduce and eliminate irritation of the tissue andthe cascade of events resulting from a foreign body response.

Another exemplary embodiment of the present invention providing such atwo-part hub with a flexible catheter is illustrated in FIG. 11 . Thedevice 140 of FIG. 11 comprises a housing 142 and housing adhesive 144,and a needle hub 146 and needle hub adhesive 148. A flexible connection150 is provided between the outer housing 142 and the needle hub 146,such that the outer housing 142 can provide an envelope for theattachment and location of the needle hub 146 therein, but any force ormovement conveyed to the outer housing 142 is not transferred to theneedle hub 146 and catheter 152.

Still further, the exemplary embodiments of the present inventiondescribed above can be used in a device with one or more additionalfeatures for the retraction of the insertion cannula or in-dwellingcatheter either within a sleeve or over a sleeve to cover the sharp edgeof the insertion cannula or in-dwelling catheter. FIGS. 12A and 12B, andFIGS. 13A and 13B are enlarged cross-sectional views of exemplary hubdevices with a retractable insertion cannula or in-dwelling catheterthat is either flexible or rigid in nature, in accordance with anotherembodiment of the present invention.

As shown in FIG. 12A, the device 160 can comprise an outer hub 162,inner hub 164, retractable insertion cannula or in-dwelling catheter166, and a blunt cannula 168. A retraction system comprising a pushbutton or other lever 170 can be provided through the outer hub 162 tosecure and then release the insertion cannula or in-dwelling catheter166 as urged by a biasing element such a spring. The button 170 cancomprise a shoulder, detent or other similar element to hold a positionof the insertion cannula or in-dwelling catheter 166 through contact,such as the contact between detent 174 and shoulder 176 of the insertioncannula or in-dwelling catheter 166.

When pressed, the button 170 releases the shoulder 176 and the insertioncannula or in-dwelling catheter is urged upward by the spring 172 for ashort distance, thereby shielding the sharpened end of the insertioncannula or in-dwelling catheter within the blunt cannula 168. Fluidcommunication to the insertion cannula or in-dwelling catheter is thenachieved through the connection of tubing 178. In the embodiment shownin FIG. 12A, the insertion cannula or in-dwelling catheter 166 isretracted upward within the blunt cannula 168 as shown in the retractedillustration of FIG. 12B.

A second exemplary embodiment is shown in FIG. 13A, wherein the device180 can comprise an outer hub 182 and outer hub adhesive layer 184,inner hub 186 and inner hub adhesive layer 188, blunt cannula 190, and aretractable insertion cannula or in-dwelling catheter 192. A retractionsystem is activated by simply pressing down on the outer hub 182. Asshown in FIG. 13B, when the outer hub 182 is pressed down to be affixedto the skin surface, the over-center hinges 194 permit travel of theinner hub 186 which retracts the retractable insertion cannula orin-dwelling catheter 192 over the blunt cannula 190 such that thesharpened end of the insertion cannula or in-dwelling catheter is raisedabove the end of the blunt cannula 190 as shown in FIG. 13B. Fluidcommunication to the catheter is then achieved through the connection oftubing 196. The inner hub 186 can further comprise any number ofsuitable sealing elements between inner and outer needles using forexample, a seal or lubricant.

FIG. 14 illustrates such a partially retracting needle concept whereinthe insertion cannula or in-dwelling catheter that is either flexible orrigid in nature, is shown in a pre-use position with a sharpened endexposed, a post-use position where the insertion cannula or in-dwellingcatheter and sleeve are shown in an SC tissue position, and in aretracted position wherein the insertion cannula or in-dwelling catheteris retracted within the outer sleeve a distance sufficient to cover thesharpened end of the insertion cannula or in-dwelling catheter. Bypartially removing the insertion cannula or in-dwelling catheter afterinserting the insertion cannula or in-dwelling catheter, the sharpenedend of the insertion cannula or in-dwelling catheter is no longerexposed and allowed to irritate the SC tissue. Further, kinking of theTeflon® or Vialon® insertion cannula or in-dwelling catheter can bereduced by leaving the insertion cannula or in-dwelling catheter in theouter sheath in the inserted position. Although the embodiment of FIG.14 is shown in use in a subcutaneous (SC) infusion, the embodiment canalso be used in intradermal (ID) infusions, intramuscular (IM)infusions, and intravenous (IV) infusions. Further, the in-dwellingcatheter shown in FIG. 14 can be either rigid/solid (i.e. withoutslots), or flexible (i.e. with slots).

A further embodiment is shown in FIG. 15 wherein the catheter isconfigured to provide infusion to both intradermal (ID) tissue andsubcutaneous (SC) tissue, either simultaneously or each intermittentlyas required to satisfy the drug delivery needs of the patient. Asdescribed in the previous embodiments, the insertion cannula retracts toprotect the tissue from the sharp edges of the needle tip, after placingthe catheter into the tissue. The insertion cannula or introducer needlein FIG. 15 is shown in the retracted position, and the needle is formedin a manner to provide two distinct fluid paths in combination with thepolymer outer sleeve.

In the exemplary embodiment shown in FIG. 15A, a device 200 is shownincluding a formed cannula such as the exemplary steel cannula 202, overwhich a sleeve such as the polymer sleeve 204 is formed, and which arefurther aligned in a manner to provide fluid communication between each,via a cross-port 206, 208 and 210. The cross-port 206 is provided to bein fluid communication with chamber 212, and the cross-port 208 isprovided to be in fluid communication with chamber 214. In the exemplaryembodiment shown, the chamber 212 is in fluid communication with a firstreservoir providing for example, a fast-acting medicament, and thechamber 214 is in fluid communication with a second reservoir providingfor example, a slow-acting medicament (see for example, FIG. 16 ). Eachelement can be supported within or upon an infusion hub 216.

As described in greater detail below, the device 200 of FIG. 15A can beplaced upon an insertion site to reach the ID tissue space 218 and an SCtissue space 220. In the exemplary embodiment shown, the cross-port 210is configured to access the ID tissue space 218, and an open proximalend of the steel cannula 202 and the polymer sleeve 204 is configured toaccess the SC tissue space 220. Specifically, the steel cannula 202 iscrimped fully closed at a distal end 222 shown by view A-A of FIG. 15B,fully uncrimped at a point shown by view B-B of FIG. 15C, partiallycrimped at a point shown by view C-C of FIG. 15D, and fully uncrimped ata point shown by view D-D of FIG. 15E, and wherein at least the furtheropening 230 is provided. In doing so, the single steel cannula 202 andpolymer 204 create first and second flow paths 226 and 228, wherein flowpath 226 is configured to provide communication between the cross-port206 and the cross-port 210, and the flow path 228 is configured toprovided communication between the cross-port 208 and the open proximalend 224 via the opening 230. The steel cannula can be sharpened at thisend as shown, or can be blunt.

The first path 226 which provides fluid to the intradermal (ID) tissue218 is through the cross-port 206 in the cannula 202 which aligns with asimilar opening in the polymer sleeve 204, when the cannula 202 is inthe retracted position. The fluid path 226 continues through theinternal lumen of the cannula 202 and exits through a similar cross-port210 into the intradermal (ID) tissue 218. The second fluid path 228 isthrough the cross-port 208 in the external polymer sleeve 204 andcontinues in the lumen created between the inner surface of the polymersleeve 204 and the outer surface of the cannula 202, and exits outthrough the end 224 of the catheter into subcutaneous (SC) tissue 220.This alternative embodiment enables infusion into at least two sites,e.g. intradermal (ID) tissue and subcutaneous (SC) tissue, each tissuehaving distinctive behavior for insulin up-take as described in U.S.Patent Publication No. 2002/0095134, of Pettis et al., the entiredisclosure of which being expressly incorporated herein by reference.

With infusion pump therapy, basal insulin infusion is continuousthroughout the day with subtle changes in the infusion rate tocompensate for changes in activity and stress. Traditionally, basalrequirements have been satisfied by slow-acting insulin. Bolus insulininfusion is used to compensate for carbohydrate consumption at meals andalso to correct for high blood glucose, i.e. hyperglycemia. Fast-actinginsulin provides the best therapy for bolus infusion. Insulin up-take ismuch faster in intradermal (ID) tissue as compared to subcutaneous (SC)tissue. Therefore, the exemplary embodiment shown in FIG. 15A can beused to infuse fast-acting insulin into the intradermal (ID) tissue forbolus requirements and infuse slow-acting insulin into subcutaneous (SC)tissue for basal requirements.

As shown in FIG. 16 , an exemplary infusion pump 232 is shown that isconfigured to support the device 200 of FIG. 15A. The infusion pump 232can incorporate at least two reservoirs 234 and 236, one for fast-actinginsulin and a second for slow-acting insulin. The infusion set canfurther provide two separate lumens 238 and 240, which would connect tothe separate chambers within the set hub. In yet another exemplaryembodiment of the present invention, the two separate lumens 238 and 240can be incorporated into a single lumen with multiple channels (notshown).

Yet another exemplary embodiment of the present invention can include aformed cannula as shown in FIG. 17A, wherein the cannula has beenreplaced with a solid rod into which two channels have been formed ormachined. Specifically, the cannula of the device 250 has been replacedwith a solid rod 252 into which two channels 256 and 258 have beenformed or machined. The remaining features are substantially asdescribed in regard to FIG. 15A. The cross-ports 206 and 208 in theexternal polymer sleeve 204 in combination with the channels 256 and 258provide two separate fluid pathways to deliver different or similardrugs to the intradermal (ID) tissue and subcutaneous (SC) tissue in amanner substantially similar to that of FIG. 15A. A perspective view ofthe exemplary solid rod 252 into which two channels 256 and 258 havebeen formed or machined is shown in FIG. 17B. As with the exemplaryembodiments described above, the rod 252 can be sharpened at the end asshown, or can be blunt.

In yet another embodiment, shown in FIGS. 18A-18E, a dual lumen catheteror cannula 260 can be formed from a flat sheet of any suitable materialas shown in FIG. 18B, rolled in the direction of arrows A and B as shownin FIG. 18C until substantially reaching a final desired shape as shownin FIG. 18D, and then either welded to close and seal the lumens asshown in FIG. 18E, or captured within an external polymer sleeve (notshown), such that two separate fluid pathways 262 and 264 are providedto deliver different or similar drugs to the intradermal (ID) tissue andsubcutaneous (SC) tissue. Alternately, the dual lumen cannula 260 can beextruded or injection molded into a form that is similar to those shownin FIGS. 17A-17B and 18A-18D. For example, the extrusion process wouldproduce a continuous cross-section, similar to that shown in FIG. 18E.Injection molding could be utilized to produce the cannula shown inFIGS. 17A and 17B.

In still another exemplary embodiment of the present invention shown inFIG. 19 , two or more separate catheters can be used to provide thedesired two or more separate fluid pathways to deliver different orsimilar drugs to the intradermal (ID) tissue and subcutaneous (SC)tissue. The exemplary embodiment shown in FIG. 19 includes the device270 having the two separate catheters 272 and 274, and is shownconnected to the exemplary infusion pump 232 incorporating at least tworeservoirs, one for fast-acting insulin and a second for slow-actinginsulin. In the exemplary embodiment shown, the catheter 272 can beprovided for targeting the ID tissue, and the catheter 274 can beprovided for targeting the SC tissue.

Currently marketed insulin infusion pumps only have a single reservoir,and fast-acting insulin is typically used to reduce complications fromoverlapping doses. Although the use of these pumps does not allowcombination drug therapy, e.g. fast-acting insulin infusion incombination with slow-acting insulin infusion, many of the benefitsstated above can be realized by infusing fast-acting insulin to both theintradermal (ID) tissue and subcutaneous (SC) tissue. Since it ispreferred to infuse bolus dosages into the intradermal (ID) tissue andbasal infusion into the subcutaneous (SC) tissue, in yet anotherexemplary embodiment of the present invention a valve arrangement can beprovided, such as with the infusion hub, to redirect the high-pressurebolus dose to the intradermal (ID) tissue. FIG. 20 illustrates anexemplary hub 280 having such a valve 282 disposed within the hub andcoupled between the first and second chambers 212 and 214, and theinfusion pump (not shown). The valve can be any suitable valve, such asthe solenoid activated valve 282 shown in FIG. 20 . For example thevalve shown is a two-position, solenoid operated, spring return valve.The valve is shown in the normal, i.e. spring return, state, which wouldcorrespond with infusion into the subcutaneous (SC) tissue. Actuatingthe solenoid would shift the valve to allow flow to intradermal (ID)tissue.

In use, the device 280 can be used to redirect flow utilizing theelectronically operated valve 282 as shown in FIG. 20 , which couldoperate from a wireless signal, such as those described in U.S. patentapplication Ser. No. 12/458,807, of Searle et al., filed Jul. 23, 2009,the entire disclosure of which being expressly incorporated herein byreference, or a signal transmitted over an electrical line that isincorporated into the infusion set and allows the controller in the pumpto communicate with the electronic valve in the infusion set hub. Theelectrical line could also be utilized to provide communication from asensor, e.g. a blood glucose sensor, to the controller in the pump. Thevalve 282 can be further provided with a manual activation button toallow the user to manually shift the valve as described.

In yet another exemplary embodiment of the present invention, a valvesystem can be configured as shown in FIG. 21A, to redirect the highpressure bolus dose to the intradermal (ID) lumen of the catheter andfollowing completion of the bolus infusion, as the pressure drops,direct the low-pressure basal infusion to the subcutaneous (SC) lumen ofthe catheter. In the valve configuration 284 shown in FIG. 21A, anumbrella check valve 286 is used in combination with a duck-bill checkvalve 288, but is not limited thereto.

In the exemplary embodiment shown in FIGS. 21A-21B, the port or hole 296in the umbrella check valve 288 allows insulin that enters opening 294as the basal or low-pressure flow from the infusion pump (not shown), toflow through and enter the subcutaneous (SC) lumen 292 of the catheter(not shown), while the fluid pressure is low as shown in FIG. 21B. Inthis position, the duck-bill check valve 286 is closed preventing flowthrough the intradermal (ID) lumen 290 of the catheter.

When the fluid pressure exceeds the cracking pressure of the umbrellaand duck-bill check valves, i.e. during bolus infusion, the umbrellacheck valve 288 opens, blocking the subcutaneous (SC) lumen pathway 292as shown in FIG. 21A, and the duck-bill check valve 286 opens allowingflow through the intradermal (ID) lumen 290 of the catheter. Followingbolus delivery, the pressure reduces and allows the duck-bill andumbrella check valves to reset to their normally closed condition, i.e.to allow basal flow through the subcutaneous (SC) lumen 292 of thecatheter as shown in FIG. 21B. In doing so, the pressures associatedwith the desired infusion are used as the valve control in the exemplaryembodiments.

Although only a few exemplary embodiments of the present invention havebeen described in detail above, those skilled in the art will readilyappreciate that many modifications are possible in the exemplaryembodiments without materially departing from the novel teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention.

What is claimed is:
 1. A method of making an in-dwelling catheter,comprising the steps of: heating a polymer to a desired temperature;injection molding an in-dwelling catheter using said heated polymer toform a rigid body portion, at least one a flexible body portioncomprising a body wall wherein one or more lengths of said wall areprovided with one or more radial openings, axial openings, channels,grooves, or separations, and a sharpened portion at one end thereof; andapplying an outer sleeve to at least a portion of said in-dwellingcatheter.
 2. A method of making an in-dwelling catheter as claimed inclaim 1, further comprising the step of injection molding thein-dwelling catheter to form a catheter body comprising a plurality ofseparated axial openings passing through at least a portion of saidcatheter body.
 3. A method of making an in-dwelling catheter as claimedin claim 1, further comprising the step of overmolding at least aportion of said in-dwelling catheter with said outer sleeve.
 4. A methodof making an in-dwelling catheter as claimed in claim 1, furthercomprising the steps of: extruding said outer sleeve; and assemblingsaid extruded outer sleeve with at least a portion of said in-dwellingcatheter.
 5. A method of making an in-dwelling catheter, comprising thesteps of: forming, casting, extruding, injection molding, or machining asolid rod to create a multi-lumen catheter comprising a plurality ofseparated axial grooves passing over at least a portion of said catheterbody; and applying an outer sleeve to at least a portion of saidcatheter body.
 6. A method of making an in-dwelling catheter as claimedin claim 13, further comprising the step of overmolding at least aportion of said catheter body with said outer sleeve.
 7. A method ofmaking an in-dwelling catheter as claimed in claim 13, furthercomprising the steps of: extruding said outer sleeve; and assemblingsaid extruded outer sleeve with at least a portion of said catheterbody.
 8. A method of making an in-dwelling catheter as claimed in claim13, further comprising the step of forming a plurality of grooves on anouter surface of said multi-lumen catheter to produce said lumensbetween an outer surface of said multi-lumen catheter and an innersurface of said outer sleeve.
 9. A method of forming an in dwellingcannula comprising the step of: providing a flexible helical coilcomprising an axial passage extending from a proximal end of the coil toa distal end of the coil; and covering the flexible helical coil with awatertight sleeve.
 10. The method of claim 17, further comprising thestep of forming a sharpened distal tip.
 11. The method of claim 17wherein the covering step comprises overmolding the sleeve onto theflexible helical coil.